Delivering bioabsorbable fasteners
An apparatus for delivering bioabsorbable fasteners comprises a housing and an actuator movable by a user to deliver one fastener at a time.
Latest Opus KSD Inc. Patents:
This application is a continuation of U.S. patent application Ser. No. 13/755,540, filed Jan. 31, 2013, now U.S. Pat. No. 9,232,943.FIELD OF THE INVENTION
The invention relates to sequentially deploying a plurality of bioabsorbable fasteners into tissue to secure two sides of an incision or cut in the skin or other tissue of a patient.BACKGROUND OF THE INVENTION
There are many examples of surgical staplers which deliver staples one at a time. Most of these deliver traditional metal staples which rely on the strength of the staple to pierce the tissue and to hold the tissue surfaces together. Hence the typical surgical stapler engages the first staple at the front of a linear array of staples, and pushes it into the tissue while bending it over an anvil. Once the staple is bent into position, the tissue surfaces that are being held cannot un-bend the metal staple. One of the disadvantages of the metal staple is that it must have a portion that remains exposed through the skin surface in order to allow a medical professional to remove the fastener once biological healing is complete. This exposed portion is unsightly, and the puncture points where the fastener enters the skin, have a risk of infection.
To address the disadvantages of metal staples, various inventors have proposed fasteners made of bioabsorbable materials which can be placed below the surface of the skin. This subcuticular skin closure avoids punctures through the epidermis, and does not require follow-up removal of the staples. Such a fastener is described in U.S. Pat. No. 6,726,705 to Peterson et al, as a “Mechanical Method and Apparatus for Bilateral Tissue Fastening”. A product based on this patent, the INSORB® Subcuticular Skin Stapler, has been commercialized by Incisive Surgical of Plymouth, Minn. The fastener deployed by the INSORB device is significantly thicker in cross section than a metal staple to enable the plastic material to be strong enough to maintain the traditional “U” shape of a staple during the healing process. This added bulk is undesirable as it takes longer to be absorbed by the body. Also the head of the INSORB stapler must be inserted within the incision to deploy the fastener. This means that the user has poor visibility as to the placement of the fastener and that the device cannot be used on small incisions such as those employed in increasingly popular minimally invasive surgery.SUMMARY OF THE INVENTION
An objective of the present invention is to provide a stapler apparatus, that is easily operated by a user, to aid in the insertion of one or more bioabsorbable fasteners for closing incisions, including small incisions such as ones that are less than 10 mm long. Another objective of the present invention is to provide good visibility to the operator of the site where the fastener will be inserted. Yet another objective is to provide a stapler loadable, or preloaded, with multiple fasteners stored in a magazine or cartridge, where the stapler is able to deploy the fasteners one at a time. A sufficient number of fasteners can be loaded or preloaded, or different configurations of the stapler can be provided, to close long as well as short incisions. Another objective of the present invention is to provide a locking mechanism that prevents fasteners from being accidentally discharged during shipment or handling prior to intentional use. An additional objective is to provide a stapler with a safety mechanism that prevents the needles from being exposed after the last fastener is delivered by the stapler.
The present application and invention is directed to a surgical stapling apparatus able to deploy fasteners of the type described by Danielson et. al. in US patent application publication number 2009/0206127 A1 “Tissue Fasteners and Related Insertion Devices, Mechanisms, and Methods” (hereinafter “Danielson”), which is incorporated herein by reference in its entirety. The present invention relates to a new and innovative delivery device that is not disclosed in Danielson and that can be used by an operator (such as a surgeon or other medical professional) to insert into tissue of a patient (such as a human or other mammal) the bioabsorbable fasteners disclosed in Danielson and to insert them generally in accordance with the insertion procedure/steps set forth in Danielson. Other types of bioabsorbable fasteners may also be used with and deployed by the disclosed apparatus.
The present invention relates to a mechanical apparatus for inserting needles into cannulated legs of a bioabsorbable fastener. The apparatus comprises a housing which orients and constrains other elements of the apparatus. Extending from the proximal end of the housing is an actuator that may be operated by the thumb of the user such that pressing the actuator into the housing causes a fastener, carried on needles and pushed by components operably connected to the actuator, to be deployed from the distal end of the housing. The housing further contains a magazine with a plurality of fasteners positioned on a reciprocally movable fastener support and a timing lever, which acts on the fastener support to move it and release each fastener one-by-one after the needles are inserted into the cannulated legs.
As the user continues to push the actuator, the needles and fastener exit the distal end of the housing and deliver the fastener between the two sides of a bifurcated foot over which the two sides of a patient's incision or cut have been positioned. The user has complete visibility of the fastener as it exits the housing before it enters the tissue, and thus can adjust the position of the stapler or tissue to precisely direct the fastener to the desired target. With manual control of speed and force, the user can deploy the fastener into the tissue such that the two legs of the fastener are inserted into the two sides of the incision. Upon releasing the actuator, it is returned by a spring to its starting position, thereby retracting the needles and leaving the fastener deployed beneath the surface of the tissue.
In order to reliably guide the needles into the cannulated legs of each fastener, the apparatus further comprises needle guide tubes made of cylindrical tubes which have an outside diameter similar in size to the outside diameter of the legs of the fastener. The distal ends of these needle guide tubes are slideably held by shaped features at the front of the magazine (“huggers”) which simultaneously contact and align the needle guide tubes and the legs of the fastener as the needles exit the needle guide tubes and enter the fastener legs. The huggers reduce the impact of normal manufacturing and assembly imperfections and tolerances, and allow the critical step of inserting the needles into the cannulated legs of the fasteners to be achieved reliably, and repeatedly, for each and every fastener loaded (or preloaded) into the apparatus.
In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:
Now with reference to
Now the various components of the apparatus 10 will be identified with reference to
Now turning to
Needles 65a,b are long and extend distally through the entire length of needle guide tubes 67a,b. The needle guide tubes 67a,b are rigidly attached to guide tube support 73. The travel of the guide tube support 73 is guided by guide tongues 59a,b which slide in guide grooves 82a,b (see
The actuator 40 is able to push and pull the guide tube support 73, but does so indirectly by making contact with different surfaces at different times, as will be described below. A frictional engagement is provided by detent-protrusion 91 on guide tube support 73, which contacts a detent-receiver 93 on actuator 40. As the user continues to press on actuator thumb pad 43, the actuator moves and contact surface 105 on the actuator comes into contact with push-pull tab 107 on the guide tube support 73. This allows force to be transferred to needle guide tubes 67a,b to push the fastener into the tissue, as will be explained with reference to
Continuing with reference to
Finally shown in
The present invention will be better understood from a description of the different actions involved in deploying a fastener. The different steps are illustrated in
Continuing with reference to
The exemplary embodiment of the present invention shown in
Continuing with reference to
When all fasteners have been deployed, a safety mechanism is introduced that prevents the needles 65a,b from being extended again. This is accomplished by pusher stop surface 286 which is the front-most portion of pusher 275. After the last fastener is delivered and the needle guide tubes 67a,b move up and out of the way, pusher 275 moves forward (left in
Continuing with reference to
Continuing with reference to
Needles 65a,b are made from surgical grade stainless steel or other similarly strong material(s) and sharpened with a conical point by means familiar to those in the art. The needle guide tubes 67a,b are made from stainless steel and have an external surface that is similar in shape and size to the external surface of the fastener legs 317a,b. Other material(s) can be used to make the needle guide tubes 67a,b. In a preferred embodiment, the needle guide tubes 67a,b and fastener legs 317a,b are cylindrical in shape and have the same outside diameter. The needle guide tubes 67a,b are spaced apart by a distance equal to the distance separating fastener legs 317a and 317b from one another. The needle guide tubes 67a,b are rigidly fixed to the guide tube support 73 by means known in the art. In one embodiment, the guide tube support 73 is made by injection molding using a material such as Acrylonitrile Butadiene Styrene (ABS) or acrylics (for example, Cyrolite® acrylic based compounds available from Cryo Industries, Rockaway, N.J.). The needle guide tubes 67a,b may be separately fabricated with a spacer-attachment structure to hold them parallel to each other. the needle guide tubes 67a,b with such an attachment structure may be attached to guide tube support 73 by means know in the art such as screws, thermo-staking, or adhesive bonding. The stainless steel needle guide tubes 67a,b may also be insert molded to be part of guide tube support 73 as a molded part.
The apparatus of the present invention has been described with reference to ten (10) bioabsorbable fasteners of the type described by Danielson (US patent application publication number 2009/0206127 A1). Those skilled in the art will realize that the benefits of the invention may be applied to other fasteners, whether made from bioabsorbable materials or not. Realizing that the objective is to deliver fasteners one at a time from a cartridge having a multiplicity of fasteners, it will be apparent that the apparatus may be adapted by obvious modifications to deliver fasteners in greater or lesser number than ten. Alternate embodiments also can work with fasteners having a greater or lesser number of legs than two. Fasteners that do not have cannulated legs can benefit from the present invention if such fasteners are adapted to have features such as holes or slots into which guiding elements, for example needles, may be inserted. While the present invention has been set forth in terms of a specific embodiment or embodiments, it will be understood that the present invention herein disclosed may be modified or altered to other configurations. Accordingly, the invention is not limited only to disclosed details.
1. Apparatus for delivering bioabsorbable fasteners that each includes a first leg and a second leg, the apparatus comprising:
- a housing configured to be held by a hand of a user, the housing having a proximal end, a distal end, and a length;
- an actuator extending out of the proximal end of the housing and configured to be moved by the user along the length of the housing and at least partially into the housing;
- a pair of needles operably connected to the actuator;
- an alignment surface configured to axially align at least one of the needles with at least one of the first and second legs of the fastener;
- a magazine comprising a plurality of the fasteners and a pusher configured to urge one of the plurality of fasteners at a time into contact with the alignment surface;
- needle guides configured to slideably guide the needles when the actuator is moved by the user to allow the needles to engage the first and second legs of the fastener, the needles and the engaged fastener exiting the distal end of the housing when the user moves the actuator; and
- a fastener support configured to move as a result of the actuator being moved by the user, movement of the fastener support releasing from the magazine the one fastener that is engaged with the needles and in contact with the alignment surface.
2. The apparatus of claim 1 further comprising a locking mechanism that prevents the fastener from exiting the distal end of the housing prior to user manipulation of the locking mechanism.
3. The apparatus of claim 1 further comprising a safety mechanism that prevents the needles from being exposed out of the distal end of the housing after all of the plurality of the fasteners have exited the distal end of the housing.
4. The apparatus of claim 1 further comprising a spring operatively connected to the actuator and configured to be deformed when the user moves the actuator at least partially into the housing and to provide restoring force to return the actuator to a starting position when the user releases pressure on the actuator.
|3716058||February 1973||Tanner, Jr.|
|4179063||December 18, 1979||Russell|
|4410125||October 18, 1983||Noiles et al.|
|4627437||December 9, 1986||Bedi et al.|
|4669473||June 2, 1987||Richards et al.|
|4736746||April 12, 1988||Anderson|
|4994073||February 19, 1991||Green|
|5089009||February 18, 1992||Green|
|5269783||December 14, 1993||Sander|
|RE34891||April 4, 1995||Kunreuther|
|5466243||November 14, 1995||Schmieding et al.|
|5489287||February 6, 1996||Green et al.|
|5515797||May 14, 1996||Janouschek et al.|
|5584859||December 17, 1996||Brotz|
|5615816||April 1, 1997||Deschenes et al.|
|5641234||June 24, 1997||Blumberg|
|5643319||July 1, 1997||Green et al.|
|5718359||February 17, 1998||Palmer et al.|
|5755371||May 26, 1998||Huang|
|5810851||September 22, 1998||Yoon|
|5891168||April 6, 1999||Thal|
|5984949||November 16, 1999||Levin|
|6179840||January 30, 2001||Bowman|
|6190401||February 20, 2001||Green et al.|
|6200330||March 13, 2001||Benderev et al.|
|6325007||December 4, 2001||Farmer|
|6387113||May 14, 2002||Hawkins et al.|
|6423073||July 23, 2002||Bowman|
|6485504||November 26, 2002||Johnson et al.|
|6551343||April 22, 2003||Tormala et al.|
|6554852||April 29, 2003||Oberlander|
|6601748||August 5, 2003||Fung et al.|
|6610079||August 26, 2003||Li et al.|
|6652563||November 25, 2003||Dreyfuss|
|6726705||April 27, 2004||Peterson et al.|
|6733506||May 11, 2004||McDevitt et al.|
|6830573||December 14, 2004||Strong et al.|
|6991643||January 31, 2006||Saadat|
|7004950||February 28, 2006||Collins et al.|
|7028878||April 18, 2006||Bauer|
|7033379||April 25, 2006||Peterson|
|7048171||May 23, 2006||Thornton et al.|
|7056331||June 6, 2006||Kaplan et al.|
|7104999||September 12, 2006||Overaker|
|7112214||September 26, 2006||Peterson et al.|
|7118581||October 10, 2006||Friden|
|D532107||November 14, 2006||Peterson et al.|
|7413570||August 19, 2008||Zamierowski|
|7547315||June 16, 2009||Peterson et al.|
|7682372||March 23, 2010||Peterson|
|7686200||March 30, 2010||Peterson|
|D635259||March 29, 2011||Peterson et al.|
|7950559||May 31, 2011||Peterson et al.|
|8016867||September 13, 2011||Bowman|
|8066736||November 29, 2011||Peterson et al.|
|8074857||December 13, 2011||Peterson et al.|
|8100939||January 24, 2012||Peterson|
|8105342||January 31, 2012||Onuki et al.|
|8506591||August 13, 2013||Danielson et al.|
|8821517||September 2, 2014||Peterson et al.|
|8821939||September 2, 2014||Ryan et al.|
|9232943||January 12, 2016||Rogers|
|20010027322||October 4, 2001||Bowman|
|20010039436||November 8, 2001||Frazier et al.|
|20020111641||August 15, 2002||Peterson et al.|
|20030167072||September 4, 2003||Oberlander|
|20030208211||November 6, 2003||Kortenbach|
|20030236550||December 25, 2003||Peterson|
|20040059377||March 25, 2004||Peterson et al.|
|20050116008||June 2, 2005||Thornton et al.|
|20050149064||July 7, 2005||Peterson et al.|
|20050288689||December 29, 2005||Kammerer et al.|
|20060009792||January 12, 2006||Baker et al.|
|20060011693||January 19, 2006||Wywialowski et al.|
|20060097027||May 11, 2006||Brown|
|20060122635||June 8, 2006||Naegeli et al.|
|20060135988||June 22, 2006||Peterson|
|20060253131||November 9, 2006||Wolniewicz|
|20080249563||October 9, 2008||Peterson et al.|
|20090206127||August 20, 2009||Danielson et al.|
|20100292715||November 18, 2010||Nering et al.|
|20120083831||April 5, 2012||Peterson|
|20120145765||June 14, 2012||Peterson et al.|
|20120325889||December 27, 2012||Danielson et al.|
|20160242772||August 25, 2016||Peterson et al.|
- Examination Report dated Mar. 24, 2017 for Indian Patent Application No. 5191/KOLNP/2008 (9 Pages).
- International Preliminary Report on Patentability for corresponding international application No. PCT/US07/15418, dated Jan. 6, 2009, 4 pages.
- International Search Report for corresponding international application No. PCT/US07/15418, dated Sep. 8, 2008, 6 pages.
- Extended European Search Report for Application No. 07810174.8, dated Dec. 21, 2012, 8 pages.
- Written Opinion of the International Searching Authority for corresponding international application No. PCT/US07/15418, dated Jan. 1, 2009, 3 pages.
- SubQ It!™ Bioabsorbable Skin Stapler 90 Day Animal Study. Opus KSD, Inc., 2013 [retrieved on Oct. 23, 2013]. Retrieved from the Internet: <URL: http://www.subq-it.com/#!studies/cfvg <http://www.subq-it.com/>.
- Danielson, Kenneth S., et al., Assessment of a Novel Subcutaneous, Bioabsorbable Skin Closure System, Presented Apr. 20, 2013 Emerging Technology Session, SAGES 2013 annual meeting, Baltimore, MD [retrieved on Oct. 23, 2013]. Retrieved from the Internet: <URL: http://media.wix.com/ugd/f91d84_9056cb0c70e64ac2f1202949444921bc.pdf>.
- Extended European Search Report for Application No. 13194162.7, dated May 8, 2014, 7 pages.
- Extended European Search Report for Application No. 15167751.5, dated Jan. 20, 2016, 9 pages.
- Declaration of Charles H. (Chuck) Rogers, Exhibit 1002, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (22 pages).
- Patent Owner Letter, Exhibit 1009, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (2 pages).
- Principles of Wound Management, Exhibit 1013, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (9 pages).
- Pediatric Emergency Procedures, Exhibit 1014, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (7 pages).
- Ethicon Wound Closure Manual Excerpts, Exhibit 1015, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (11X pages).
- Photographs, Exhibits 1007A and 1007B, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (4 pages).
- Photograph, Exhibit 1010, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (2 pages).
- Photograph, Exhibit 1011, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (2 pages).
- Declaration of H.V. Mendenhall, Exhibit 1017, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated May 15, 2017 (18 pages).
- Patent Owner Preliminary Response, Paper #6, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Aug. 18, 2017 (19 pages).
- Motion to Deem Material Facts Admitted, Paper #8, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 5, 2017 (11 pages).
- Reply to Preliminary Response, Paper #9, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 5, 2017 (11 pages).
- Patent Owner Sur-Reply to Petitioner Reply to Preliminary Response, Paper #10, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 12, 2017 (14 pages).
- Patent Owner Opposition to Petitioner Motion, Paper #11, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 12, 2017 (14 pages).
- Petitioner Reply to Motion to Deem Statements of Material Facts Admitted, Paper #12, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 18, 2017 (13 pages).
- Advertising Document, Exhibit 1020, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 18, 2017 (2 pages).
- Corrected Reply on Motion to Deem Statements of Material Facts Admitted, Paper #13, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. 19, 2017 (11 pages).
- Conduct of the Proceeding, Paper #7, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Sep. Aug. 30, 2017 (5 pages).
- Trial Instituted Document, Paper #14, Inter Partes Review of U.S. Pat. No. 8,821,517, AIA Review No. IPR2017-01468, dated Nov. 15, 2017 (9 pages).
- Non-Final Office Action dated Apr. 19, 2018 for U.S. Appl. No. 14/925,355 (34 Pages).
International Classification: A61B 17/068 (20060101); A61B 17/04 (20060101); A61B 17/072 (20060101);